MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[185521199]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185521200]
Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy. It was reported the patient called in for assistance with the external devices. Patient services (ps) reviewed how to use the devices. Patient said she wanted to change to program 2. During call ps reviewed how to change programs and patient was able to change to program 2. Patient said she felt stim in her hip and not the bike seat. Patient said they were never able to get stim in the bike seat. On (b)(6) 2020 the patient called in again and stated that they have been incontinent with the new device and it is not working for their symptoms at all. The patient was able to change from program 4 at 3. 5 v to program 5 at 2. 1 v where it was comfortable. The patient also stated that they were unable to get the stimulation in the bicycle seat area when they got the new implant and wanted to know if ps could get it there. The patient changed programs and reviewed how programming may need to be addressed. The patient will monitor symptoms now that a change was made and will follow up with hcp if the issues don't resolve. No further complications were reported or are anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06369 |
| MDR Report Key | 9897741 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERSTIM II |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE |
| Product Code | EZW |
| Date Received | 2020-03-30 |
| Model Number | 3058 |
| Catalog Number | 3058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |